The Evaluation for Fu's Subcutaneous Needling (FSN) in Carpal Tunnel Syndrome.

NCT ID: NCT05627349

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-20
• Study Completion Date: 2025-06-20

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of Fu's Subcutaneous Needling (FSN) in carpal tunnel syndrome (CTS). The main questions it aims to answer are:

• Dose FSN improve the symptoms of CTS?
• Dose FSN decrease cross section area of median nerve in CTS patients?
• Dose FSN have the effect of electrophysiology exam in CTS patients? Participants will receive wrist splinting and FSN treatment respectively. Researchers will compare wrist splinting group with FSN group to see if FSN being effective for CTS.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

wrist splinting group

wrist splinting at night for 2 weeks

Group Type: EXPERIMENTAL

wrist splinting

Intervention Type: DEVICE

standard wrist splinting at night for 2 weeks

FSN group

The needle inserted at the midpoint of the anterior forearm of the affected side. Swaying movement (SM) frequency is 200 times in 2 minutes. Reperfusion approach (RA) was performed with slow repetitively grasping movement while SM. On the 1st, 2nd, and 4th days, three times of FSN treatment were arranged.

Group Type: EXPERIMENTAL

FSN

Intervention Type: DEVICE

FSN is a single-use disposable needle(Trocar Acupuncture Needle, Nanjing FSN Medical Co. , Ltd, China.). The needle body is solid, and covered with a plastic tube. The needle penetrates the skin with insertion device. Under the guidance of ultrasound, the needle enter the loose subcutaneous layer obliquely without penetrating into the muscle. This is the difference from traditional acupuncture. The insertion point is midpoint of the anterior forearm. The needle tip is toward the carpal tunnel. After the needle is inserted, SM and RA are performed. The frequency of SM is 200 times in two minutes. The method of SM is to make a horizontal fan swaying with the base of the needle as the fulcrum. RA is performed while SM-slowly make a fist for 10 seconds and then relax for 5 seconds. Eight times of RA in two minutes. After the FNS treatment, the needle was withdrawn.

Interventions

wrist splinting

standard wrist splinting at night for 2 weeks

Intervention Type: DEVICE

FSN

FSN is a single-use disposable needle(Trocar Acupuncture Needle, Nanjing FSN Medical Co. , Ltd, China.). The needle body is solid, and covered with a plastic tube. The needle penetrates the skin with insertion device. Under the guidance of ultrasound, the needle enter the loose subcutaneous layer obliquely without penetrating into the muscle. This is the difference from traditional acupuncture. The insertion point is midpoint of the anterior forearm. The needle tip is toward the carpal tunnel. After the needle is inserted, SM and RA are performed. The frequency of SM is 200 times in two minutes. The method of SM is to make a horizontal fan swaying with the base of the needle as the fulcrum. RA is performed while SM-slowly make a fist for 10 seconds and then relax for 5 seconds. Eight times of RA in two minutes. After the FNS treatment, the needle was withdrawn.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female aged 20-85 years old.

2. Meet the diagnosis of mild to moderate carpal tunnel syndrome.

3. If the patient has carpal tunnel syndrome in both hands, choose the side with mild or moderate carpal tunnel syndrome.

4. After being explained, join the trial voluntarily and sign the subject's consent form.

Exclusion Criteria

1. Caused by trauma or mass lesion.

2. Thenar muscle atrophy.

3. Electrophysiological examination revealed severe CTS.

4. Chronic kidney disease, rheumatoid arthritis, abnormal thyroid function, diabetes.

5. Psychiatric history or incapable of cooperating with the investigator.

6. Pregnancy.

7. History of substance abuse or long-term steroid use.

8. History of median nerve surgery.

9. Those who do not sign the consent form.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chih Ying Wu, MD

Role: STUDY_CHAIR

China Medical University, China

Locations

China Medical University Hsinchu Hospital

Zhubei, Hsinchu County, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chih Ying Wu, MD

Role: CONTACT

zingwu1029@gmail.com

+886 4 2205 2121 ext. 5094

Facility Contacts

Chih-Ying Wu, MD

Role: primary

zingwu1029@gmail.com

+886 4 2205 2121 ext. 5094

Other Identifiers

CMUH111-REC2-065

Identifier Type: -

Identifier Source: org_study_id